Heron Therapeutics Announces Publication Showing Reduction of Pain and Opioid Use Compared to Bupivacaine in Patients 65 and Older with ZYNRELEF™
ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
In this post-hoc analysis, those 65 years and older who were administered ZYNRELEF used fewer opioids in bunionectomy and herniorrhaphy compared with bupivacaine (7.7 morphine milligram equivalents (MME) vs 15 MME, and 1.7 MME vs 3.5 MME, respectively). Importantly, a greater proportion of patients 65 years and older required no opioids (i.e., opioid-free) through 72 hours (58% vs 25%, and 87% vs 64%, respectively).
ZYNRELEF was well tolerated in patients 65 years and older, with a safety profile similar to that for bupivacaine. The safety was also similar to patients aged younger than 65 years and to the overall populations in the Phase 3 studies. No local anesthetic systemic toxicity events occurred and serious adverse events were rare with none considered related to ZYNRELEF.
"Adults ages 65 and over account for approximately half of all surgeries in
ZYNRELEF is the first and only local anesthetic that has been clinically shown to significantly reduce pain, including severe pain, better than bupivacaine, the current standard-of-care, for up to 72 hours and to significantly reduce or eliminate opioid use in many patients following surgery.
The Pain Management article can be found here.
Important Safety Information for Patients
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:
- can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
- cannot be used during heart bypass surgery.
- can increase the risk of gastrointestinal bleeding, ulcers, and tears.
ZYNRELEF should also not be used if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines; or as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are constipation, vomiting, and headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Please see full Prescribing Information, including Boxed Warning.
About ZYNRELEFTM for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the FDA in
About Heron Therapeutics, Inc.
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and
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Executive Vice President, Chief Operating Officer
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